Preterm Premature Rupture of Fetal MembranesNCT03744078
A Randomized Trial of Induction Methods in Premature Rupture of Membranes
A study testing Foley balloon catheter in people with Preterm Premature Rupture of Fetal Membranes and Induction of Labor Affected Fetus / Newborn, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 2 sites in Turkey (Türkiye).
Trial summary
This study evaluates the addition of transcervical Foley catheter balloon and vaginal prostaglandin E2 induction in premature rupture of membranes. Half of participants will be used combine transcervical Foley catheter balloon and vaginal prostaglandin E2, while the other half will be used alone vaginal prostaglandin… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Premature Rupture of Fetal Membranes, Induction of Labor Affected Fetus / Newborn
- What is being tested?
- Foley balloon catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Apr 2018to 1 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- singleton pregnancy,
- gestational age ≥34 weeks,
- rupture of membranes,
- cephalic presentation,
- bishop score ≤5,
- had less than three uterine contractions in every 10 minutes.
Who cannot join
- Patients who had contraindications for vaginal delivery,
- previous uterine surgery,
- fetal malpresentation,
- multifetal pregnancy,
- more than three contractions in 10 minutes,
- contraindications to prostaglandins,
Show all 10Show fewer
- a category II or III fetal heart rate pattern,
- anomalous fetus,
- fetal demise
- women with immediate delivery indications -
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Doga
Istanbul, Kucukcekmece, 34303
Doga Seckin, 905065152715, doga_seckin@hotmail.com
Doga Seckin
- Recruiting
Zeynep Kamil Education and Research Hospital
Istanbul, Uskudar, 34668
ahmet eser, 905067136880, hicoice@yahoo.com
ahmet eser, hicoice@yahoo.com
About this study
Official title: A Randomized Trial of Foley Bulb and PGE2 for Labor Induction in Premature Rupture of Membranes
This study evaluates the addition of transcervical Foley catheter balloon and vaginal prostaglandin E2 induction in premature rupture of membranes. Half of participants will be used combine transcervical Foley catheter balloon and vaginal prostaglandin E2, while the other half will be used alone vaginal prostaglandin E2.
- Being tested
- Foley balloon catheter
- Medical subject headings
- Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foley balloon catheterDevice
18-F Foley catheter which filling with 60 mL of saline solution will be placed into the cervix
| Study group | Role | What they receive |
|---|---|---|
| PGE2 with Foley balloon catheter | Active comparator | 10 mg PGE2 vaginal ovul will be inserted to the posterior fornix and an 18-F Foley catheter which filling with 60 mL of saline solution will be placed into the cervix Receives: Device: Foley balloon catheter |
| PGE2 vaginal ovule | No intervention | 10 mg PGE2 vaginal ovule will be inserted to the posterior fornix |
What is being measured
The primary outcome is the main question the study is designed to answer.
induction-to- delivery time
the length of time between the beginning of induction and the end of labor
Measured: an average of one year
Secondary outcomes (5)
tachysystole
uterine contractions more than 3 in 10 minutes
Measured: an average of one year
chorioamnionitis
clinical chorioamnionitis(Maternal fever and Fetal tachycardia >160/min and Maternal tachycardia >100/min
Measured: an average of one year
postpartum hemorrhage
abnormal uterine bleeding after birth
Measured: an average of one year
neonatal outcome
APGAR scores
Measured: an average of one year
admission to neonatal intensive care unit
admission to neonatal intensive care unit
Measured: an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start15 Apr 2018
- Primary completion15 Dec 2018 (estimated)
- Study completion1 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm Premature Rupture of Fetal MembranesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Eser, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Investigators
- ahmet eser, Study director, Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744078
- Sponsor's protocol ID
- 47
- Status last verified
- Nov 2018
- First submitted
- 27 Mar 2018
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
PubMed 36996264
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Foley Bulb and PGE2 for Labor Induction in Premature Rupture of Membranes
- ClinicalTrials.gov ID
- NCT03744078
- Acronym / sponsor ID
- 47
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 15 Dec 2018 (estimated)
- Study completion
- 1 Jan 2019 (estimated)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the addition of transcervical Foley catheter balloon and vaginal prostaglandin E2 induction in premature rupture of membranes. Half of participants will be used combine transcervical Foley catheter balloon and vaginal prostaglandin E2, while the other half will be used alone vaginal prostaglandin E2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PGE2 with Foley balloon catheter | Active comparator | Device: Foley balloon catheter10 mg PGE2 vaginal ovul will be inserted to the posterior fornix and an 18-F Foley catheter which filling with 60 mL of saline solution will be placed into the cervix |
| PGE2 vaginal ovule | No intervention | –10 mg PGE2 vaginal ovule will be inserted to the posterior fornix |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- singleton pregnancy,
- gestational age ≥34 weeks,
- rupture of membranes,
- cephalic presentation,
- bishop score ≤5,
Key exclusion criteria (10 listed)
- Patients who had contraindications for vaginal delivery,
- previous uterine surgery,
- fetal malpresentation,
- multifetal pregnancy,
- more than three contractions in 10 minutes,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foley balloon catheter18-F Foley catheter which filling with 60 mL of saline solution will be placed into the cervix | Device | PGE2 with Foley balloon catheter |
Primary outcome
induction-to- delivery time
Time frame: an average of one year
the length of time between the beginning of induction and the end of labor
5 secondary outcomes
tachysystole
Time frame: an average of one year
chorioamnionitis
Time frame: an average of one year
postpartum hemorrhage
Time frame: an average of one year
neonatal outcome
Time frame: an average of one year
admission to neonatal intensive care unit
Time frame: an average of one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
- Derived from this study: PubMed 36996264de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ahmet eser study director
Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology, Istanbul, Turkey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foley balloon catheter in people with Preterm Premature Rupture of Fetal Membranes and Induction of Labor Affected Fetus / Newborn, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ahmet eser (905067136880, hicoice@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
induction-to- delivery time (time frame: an average of one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03744078, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2018.